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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameFLUOREX (TM) 600 (FLURSILFOCON A)
Classification Namelens, contact (other material) - daily
Generic Namemonofocal and tangent-streak biofocal rgp lens
Regulation Number886.5916
ApplicantG.T. LABORATORIES, INC.
PMA NumberP880001
Supplement NumberS016
Date Received06/19/1989
Decision Date07/20/1990
Product Code
HQD[ Registered Establishments with HQD ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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